title: Laboratory automation of high-quality and efficient ligand-binding assays for biotherapeutic drug development.
abstract: BACKGROUND
  Regulated bioanalytical laboratories that run ligand-binding assays in support of biotherapeutics development face ever-increasing demand to support more projects with increased efficiency. Laboratory automation is a tool that has the potential to improve both quality and efficiency in a bioanalytical laboratory. The success of laboratory automation requires thoughtful evaluation of program needs and fit-for-purpose strategies, followed by pragmatic implementation plans and continuous user support.
  
  
  RESULTS
  In this article, we present the development of fit-for-purpose automation of total walk-away and flexible modular modes. We shared the sustaining experience of vendor collaboration and team work to educate, promote and track the use of automation.
  
  
  CONCLUSIONS
  The implementation of laboratory automation improves assay performance, data quality, process efficiency and method transfer to CRO in a regulated bioanalytical laboratory environment.
authors.affiliation: Pharmacokinetics & Drug Metabolism Department, Amgen Inc., MS: 30E-3-C, One Amgen Center Drive, Thousand Oaks, CA 91320, USA. jinw@amgen.com
authors.forename: Jin
authors.initials: J
authors.lastname: Wang
authors.forename: Vimal
authors.initials: V
authors.lastname: Patel
authors.forename: Daniel
authors.initials: D
authors.lastname: Burns
authors.forename: John
authors.initials: J
authors.lastname: Laycock
authors.forename: Kinnari
authors.initials: K
authors.lastname: Pandya
authors.forename: Jennifer
authors.initials: J
authors.lastname: Tsoi
authors.forename: Binodh
authors.initials: B
authors.lastname: DeSilva
authors.forename: Mark
authors.initials: M
authors.lastname: Ma
authors.forename: Jean
authors.initials: J
authors.lastname: Lee
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000494:pharmacology; D057205:Automation, Laboratory / Q000379:methods*; D001688:Biological Products / Q000494:pharmacology*; D015415:Biomarkers / Q000032:analysis*; D002623:Chemistry Techniques, Analytical / Q000379:methods*; D000069448:Denosumab; D016903:Drug Monitoring / Q000379:methods*; D006801:Humans; D008024:Ligands; D011786:Quality Control
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D001688:Biological Products; D015415:Biomarkers; D008024:Ligands; D000069448:Denosumab